Individual Dose Packaging

ABSTRACT

A method for packaging an agent for delivery within a body cavity. A reservoir within a package contains a specified quantity of the agent and is either contiguous with, or coupled to, a dispensing node such as a swab. Depth of insertion of the dispensing node into the body cavity is restricted to a specified depth by a penetration-restricting feature that forms part of the package.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of co-pending U.S. application Ser. No.10/891,799 filed on Jul. 15, 2004, herein incorporated by reference,which claims priority from U.S. Provisional Application No. 60/487,441,filed Jul. 15, 2003, and from U.S. Provisional Application No.60/488,306, filed Jul. 18, 2003 incorporated herein, in theirentireties, by reference.

TECHNICAL FIELD

The present invention relates to the field of delivery of agents intocavities of the human body, and, more particularly, to nasal delivery ofpharmaceutical, therapeutic, nutritional, cosmetic or homeopathicagents.

BACKGROUND OF THE INVENTION

The rich vasculature of the nasal mucosa provides a desirable avenue forthe introduction of various agents. In particular, the highlyvascularized lateral wall of the bulbous portion of the nasal cavityprovides a particularly efficient route for absorption or adsorption ofsuch agents.

It is known that absorption or adsorption of a material increases withresidence time between the material and epithelial tissue in the nose,or other body cavity. On the other hand, the activity of cilia acts toclear the mucous tissue of dust or other particles trapped in mucoustissue.

Methods for delivery of agents to the nasal membranes include deliveryin the form of drops, sprays, powders, or gels. It is also known thatincreasing the viscosity of a solution of therapeutic agent may have theeffect of retaining the agent in the face of cilial action, therebyprolonging the therapeutic effect of the agent, and, thus, gels havecome to be used for delivering such agents. Examples of gel-borne agentsfor nasal delivery are provided in U.S. Pat. Nos. 6,080,783 and6,365,624, to Davidson et al., which are incorporated herein byreference.

One problem that presents itself, however, is that of optimizing theresidence time in a region of particular efficacy, and, at the sametime, providing a convenient application modality for the user that isneither messy nor difficult to use.

SUMMARY OF THE INVENTION

In a first embodiment of the invention there is provided a method forpackaging an agent, such as but not limited to a therapeutic,pharmaceutical, nutritional, cosmetic or homeopathic agent, for deliverywithin a body cavity. The method has steps of:

-   -   a. coupling a reservoir, disposed within a package and        containing a specified quantity of the agent, to a dispensing        node, the package having a penetration-restricting feature; and    -   b. coupling the dispensing node to the package in such a manner        as to limit a depth of insertion of the dispensing node into the        body cavity to a specified depth.

In accordance with further embodiments of the invention, the packagelimits the depth of insertion by providing the user with a tactile guideindicating optimal insertion depth. In accordance with furtherembodiments of the invention, the dispensing node may be a swab, and,moreover, the reservoir and the swab may be identical. The swab may becovered with a sheath impermeable to the agent that is capable ofretraction so as to expose the dispensing node for insertion into thebody cavity while allowing handling of the package without touching thetherapeutic agent.

In accordance with yet another embodiment of the invention, a pair ofreservoirs containing the agent may be provided, with each of the pairof reservoirs coupled to a separate dispensing node, where the twodispensing nodes are separated in such a manner that the dispensingnodes may be inserted simultaneously, one into each nostril of the noseof the subject.

In accordance with yet further embodiments of the invention, an agentdelivery product is provided for delivering the agent within a bodycavity. The product has a swab coated with the agent and coupled to ashaft having a length and packaging impermeable to the agent forencasing the swab, the packaging characterized by apenetration-restricting feature disposed in such a manner as to restricta depth of insertion of the swab into the body cavity to a depthdetermined by the penetration-restricting feature and the length of theshaft.

In accordance with yet further embodiments of the invention, a method isprovided for manufacture of an agent delivery product. The method ofmanufacture includes steps of:

a. forming depressions in a base sheet;

b. dispensing a gel containing the agent in the depressions in the basesheet;

c. sealing a cover sheet to the base sheet to form a sealed package; and

d. cutting the sealed package into a specified shape.

In accordance with other embodiments of the invention, a dispensing nodeis placed on the base sheet, the dispensing node being coated with anagent either before or after placement on the base sheet. Alternatively,the dispensing node may be placed in one depression on the base sheetand the agent may be placed in another depression on the base sheet forlater application.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing features of the invention will be more readily understoodby reference to the following detailed description, taken with referenceto the accompanying drawings, in which:

FIGS. 1A and 1B illustrate components of a package for an applicatorswab in accordance with embodiments of the present invention, as sealedand as opened, respectively;

FIG. 1C illustrates the penetration-restricting feature of the packagingto restrict the depth of insertion of the dispensing node into the bodycavity;

FIGS. 1D, 1E, and 1F depict sterile packaging of an applicator swab inembodiments providing for minimal packaging waste;

FIG. 2 is a top view of a swab applicator package in accordance with anembodiment of the present invention;

FIG. 3A is a cross section of an applicator package in accordance with afurther embodiment of the present invention;

FIG. 3B is a cross section of an applicator package containing aseparate gel reservoir for each nostril, in accordance with a furtherembodiment of the present invention;

FIGS. 3C and 3D illustrate inner and outer views of a package containinga soft extruded tube applicator in accordance with embodiments of thepresent invention;

FIGS. 4A and 4B illustrate cross sections of two further embodiments ofapplicator swab packages as described in the present invention;

FIG. 5 is a cross section of a swab applicator package in accordancewith yet a further embodiment of the present invention;

FIG. 6 is a cross section of an applicator package with two detachablesections with each section containing an embodiment of the presentinvention with a dispensing node; and

FIG. 7 is a perspective view showing an assembly process formanufacturing swab applicator packages in accordance with an embodimentof the present invention.

DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTS

The term “agent” as used herein refers to a substance or substances thatare introduced into the body cavity, particularly, the nasal cavity.Furthermore, the agent may be a pharmaceutical, therapeutic,homeopathic, nutritional or cosmetic agent.

Referring first to FIGS. 1A and 1B, a preferred embodiment of thepresent invention is shown, in which a dispensing node 12 is disposedwithin a consumer point-of-sale package or agent delivery productdesignated generally by the numeral 10. Dispensing node 12 may be, as inthe embodiment shown, a swab, such as a cotton pledget, coated with agel that contains an agent for introduction into a body cavity.Dispensing node 12 need not be a swab, however, and other embodiments ofthe invention with ducts are described below, for example, in referenceto FIGS. 3A, 3C and 3D.

In the present description, the body cavity to which reference is madeis typically the nose, however it is to be understood that the use ofthe methods and materials described herein in the context of other bodycavities is within the scope of the present invention. Moreover, whilethe present description refers to the agent as contained within a gel,it is to be noted that liquids or powders may be handled in analogousways, within the scope of the present invention as described herein andas claimed in any appended claims.

Package 10 is typically fabricated by joining flexible films made of anyof a variety of materials, such as plastic and foils, and, as a moreparticular example, sheets of urethane. The package may be formed byheat-welding, or otherwise joining, materials that are substantiallyimpermeable to the gel so as to prolong the shelf-life of the product.Swab 12 may be coupled to a shaft 14 which allows the swab to protrudefrom package 10 when tab 16 is removed from the package by the user inorder to expose the swab. Tab 16 is typically removed by tearing along astress concentrate in the packaging material, such as a notch or a slit.

The user may expose the swab by a variety of methods. Preferably, theuser tears across the top of the packaging material to expose the swab.Alternatively, the user may tear along the center of the packagingmaterial, that is, down from the top of the swab and towards theopposite end of the swab, to expose the swab. Furthermore, the user maytear the packaging material by grasping each half of the packagingmaterial and pulling it apart, to expose the swab.

FIG. 1B shows the applicator package 10 of FIG. 1A after opening by theuser. A collapsible sheath 18 may then be retracted, as shown in FIGS.1B and 1C, in order to expose swab 12 to allow the swab to be insertedinto the nose or other body cavity. The user holds finger tab 15,advantageously allowing the gel coating of the swab to be dispensedwhile minimizing the exposure of the user's hands to the gel.Preferably, the user's hands are not exposed to the gel. An additionaladvantage of the embodiment depicted in FIG. 1C is that the collapsiblesheath may provide tactile feedback to the user with respect to depth ofinsertion of the swab. Thus, the user may know when the swab is insertedsufficiently deeply for desired delivery of the gel by virtue of thesheath touching the edge of the nostril as shown in FIG. 1C. The lengthof shaft 14 is tailored to a desired depth of penetration relative tothe end of the retracted sheath. Sheath 18 is withdrawn, on opening,from flexible neck 13 of the applicator package.

Following retraction of the sheath 18, additional gel may be retainedwithin the sheath 18 as the sheath 18 acts as a reservoir for the gel.The sheath 18 may be subsequently extended, resulting in a furtherapplication of gel to the swab 12. Upon a further retraction of thesheath 18, gel may be applied to the same or to a different nostril.

An advantageous feature of the present invention is the amenability ofvarious of the embodiments described herein to minimal-waste packaging.For example, referring now to the embodiment depicted in FIG. 1D, withthe package cover removed, applicator swab 12 is individually packagedwithin sterile package 102, in continuous conjunction with sterilepackages 104, 106, and 108. Sterile package 108 is depicted beingdetached along perforation line 109 from adjoining package 104 and 106.An alternate packaging scheme is shown in FIG. 1E. Additionaldepressions 122 and 124 may be provided, by vacuum forming or otherwise,in the base sheet of package 120 as a supplemental reservoir of gelcontaining the agent, or to facilitate removal of shaft 14 by the user.As shown in FIG. 1E, depression 122 may be a reservoir of gel anddepression 124 may facilitate the removal of the shaft 14 by the user.FIG. 1F is a perspective view of package 120 further clarifyingdepressions 122 and 124 described above.

Referring now to FIG. 2, package or agent delivery product 20, shownhere after opening, such that coated swab 12 is exposed, may be shapedsuch as to form features such as wings 22, thereby limiting, by virtueof their lateral extent, the depth to which swab 12 may be inserted intothe user's nostril. The base portion of package 20 comprising finger tab15 is preferably flat for ease of gripping by the user.

In accordance with another embodiment of the invention depicted in FIG.3A, gel 31 containing the agent may be provided within a sealedreservoir 30 within the applicator package 20. Reservoir 30 is coupledto a dispensing node 32 via duct 38, here made accessible by the user byremoving a frangible seal 34, in this case, by tearing away tab 36. Inother embodiments of the invention, multiple reservoirs 30 may beprovided. FIG. 3B shows two reservoirs 30, each coupled to a singledispensing node 32. In this case, the user tears off tab 36, insertsdispensing node 32 and, by pressing on the outside of the package,squeezes the contents of each reservoir 30 into a separate nostril.

Referring now to FIG. 3C, showing an embodiment of the invention withouta swab, dispensing node 32 is initially provided to the consumer with aheat sealed covering 36, referred to above as a ‘tab’. Covering 36 istorn away at frangible seal 34 to expose the dispensing node. Dispensingnode 32 is coupled to gel-containing reservoir 30 by means of a duct 38,which, in the embodiment shown, is soft extruded tubing that may beused, in the manner of a swab, to deposit the gel at a preferred depthin a body cavity. Duct 38 may advantageously be formed using thesubstance to be contained within reservoir 30 for purposes ofmanufacturing the duct 38. The duct 38 may be extruded simultaneouslyinto the tube during the manufacturing process. Furthermore, the gel maybe inserted into the tube during the extrusion process. Moreover, theenclosing package 39, shown in FIG. 3D and also referred to as a ‘tab’,may serve the function, described above, of defining, by virtue of thetactile features of its width, the depth to which dispensing node 32 isoptimally inserted into the nose.

Various embodiments of the invention provide, either that swab 12 isenclosed within heat-sealed sheeting 41 to form package 40 (FIG. 4A),or, alternatively, in addition to primary seal 44, a secondary seal 46is provided that encompasses shaft 14 to form package 42 as shown inFIG. 4B.

Referring now to FIG. 5, gel reservoir 30 within heat-welded flexiblefilm enclosure 50 may be coupled to a dispensing node 32 in swab 12 by aduct 38 where fluid communication between the gel reservoir 30 and thedispensing node 32 require only open rupture by the user of frangibleseal 52. As shown in FIG. 5, preferably, there may be side fenestrations59 in the part of the duct 38 within the swab 12 to allow the gel 31 todirectly penetrate into the swab 12. Additionally, in other embodiments,the duct 38 may dispense its contents directly into the swab 12 or thebody cavity. Other embodiments of agent delivery products showing thepackaging of parallel applicators 62 are illustrated in FIG. 6, in thisembodiment, as two sections. When tear-away tab 62 is removed, twodispensing nodes 64 and 66 are exposed that may be appliedsimultaneously, one to each nostril of the user.

Disposable applicators or agent delivery products, of the sort discussedin the foregoing description, may advantageously be manufactured inaccordance with a method now described with reference to FIG. 7. A basesheet 70 of film such as urethane, or other suitable material, is drawnfrom base sheet roll 71. Vacuum former 72 draws reservoirs 73 into sheet70. Other methods, such as matched die forming, may be used for formreservoirs 73 into sheet 70. Reservoirs 73 are filled by dispensers 74with prescribed quantities of gel 75. A cover sheet of urethane is drawnfrom cover sheet roll 76 to cover the base sheet and heat-welded to thebase sheet by heat sealer 77. Unit packages are cut to shape by diecutter 78 and printing is applied to the completed packages by printer79.

In view of the foregoing, it will therefore be understood that the scopeof the invention as defined in the following claims is not limited tothe embodiments described herein, and that the above and numerousadditional variations and modifications could be made thereto withoutdeparting from the scope of the invention as defined in the followingclaims.

1. A method of manufacture for an agent delivery product, the methodcomprising: a. forming depressions in a base sheet; b. dispensing a gelcontaining the agent in the depressions in the base sheet; c. sealing acover sheet to the base sheet to form a sealed package; and d. cuttingthe sealed package into a specified shape.
 2. A method of manufacture inaccordance with claim 1, wherein the step of forming depressionsincludes vacuum forming the depressions.
 3. A method of manufacture inaccordance with claim 1, wherein the step of forming depressionsincludes matched die forming the depressions.
 4. A method of manufacturefor an agent delivery product, the method comprising: a. forming areservoir; b. filling the reservoir with an agent; and c. forming a ductin fluid communication with the reservoir by application of pressure tothe agent within the reservoir.